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PD-1 Inhibitor

TT-816 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Teon Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug (TT-816) by itself and in combination with another drug (a PD-1 inhibitor) to see if it can shrink tumors in people with advanced cancers.

Eligible Conditions

Cancer
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes from baseline in clinical safety laboratory values and vital signs

Efficacy assessments according to RECIST 1.1 (Phase 2)

Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)

+3 more

Secondary outcome measures

Disease control rate (DCR) (Phase 1)

Duration of response (DOR) (Phase 1)

Incidence of AESIs - (Phase 2)

+9 more

Other outcome measures

Food effects on PK parameters (Phase 2)

Molecular analysis of patient tissue (Phase 1 and Phase 2)

Tumor assessments (Phase 1 and Phase 2)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single agent TT-816Experimental Treatment1 Intervention

Escalating doses followed by expansion targeting advanced cancers

Group II: Combination TT-816 plus a PD-1 inhibitorExperimental Treatment2 Interventions

Escalating doses followed by expansion targeting advanced cancers

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,544 Total Patients Enrolled

Teon Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

114 Total Patients Enrolled

Teon Clinical DevelopmentStudy DirectorTeon Therapeutics, Inc.

Media Library

PD-1 inhibitor (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05525455 — Phase 1 & 2

Cancer Research Study Groups: Single agent TT-816, Combination TT-816 plus a PD-1 inhibitor

Cancer Clinical Trial 2023: PD-1 inhibitor Highlights & Side Effects. Trial Name: NCT05525455 — Phase 1 & 2

PD-1 inhibitor (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525455 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many willing participants are being enrolled in this experiment?

"That is accurate, the online clinicaltrials.gov registry has information indicating that this study is recruiting patients as of now. The original posting was on 8/29/2022, and there have been since edits made on 10/25/2022. They are looking for a total of 200 individuals from 5 different sites."

Answered by AI

Why was this research project undertaken?

"The primary objective of this study, which will run for 12 months, is to document the frequency and severity of dose-limiting toxicity (DLT) related to the experimental medication. Additional goals include measuring the drug's plasma concentration (Cmax) and area under the curve (AUC) during Phase 1 and 2 of the trial."

Answered by AI

Are recruitment efforts for this research ongoing at this time?

"The latest information from clinicaltrials.gov reveals that this study is still recruiting patients. 200 participants are needed in total, with 5 different hospitals hosting the trial."

Answered by AI

Are there are any Canadian locations conducting this research?

"If you are interested in enrolling for this trial, please note that there are 5 sites currently recruiting patients. The locations closest to Detroit are Austin and San Antonio. To limit travel, please select the clinic nearest you."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TT-816 as Monotherapy or in Combination With a PD-1 Inhibitor in Patients With Advanced Cancers (SEABEAM) (MK3475-E88)

2022. "TT-816 as Monotherapy or in Combination With a PD-1 Inhibitor in Patients With Advanced Cancers (SEABEAM) (MK3475-E88)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525455.